Golden West Biologicals, Inc. was formed in 1989 to directly access the need created by medical device manufacturers to locate a reliable source of cost effective and technically superior raw materials. In addition to these requirements, Golden West Biologicals, Inc. (GWB) is committed to providing all customers with service beyond the expected. This service not only includes on-time delivery, minimal lead-time and consistent product performance, but the undertaking of feasibility projects for specialized products without any substantial front money.
It is the policy of Golden West Biologicals, Inc to:
• Achieve customer excellence through meeting or exceeding customer expectations • Supplying customers consistently with products that conform to agreed requirements and specifications
• On time delivery
• Customer service and technical support
• Maintain the integrity of and continually improve the Quality Management System
• Comply with:
• Regulatory requirements
• Domestic and international quality standards
Quality in all activities is the single most important thing to Golden West Biologicals, Inc.
Our product mix includes most of the essential raw materials required to manufacture or develop immunoassays of any biologically important substance. These products cover the full gamut from antigens and antibodies to highly purified protein powders. Sera matrices from human or animal sources are available. The sera can be obtained in a processed condition in which the endogenous levels of select components are removed by various unique methodologies. In addition, optically clarified methods can be employed to yield aesthetically stable sera. Furthermore, recent proprietary discoveries in protease inactivation methods have extended the usefulness of these sera to sensitive biologically active molecules that heretofore were unstable. The production of antigens in bulk allows the end user high quality, low cost and sizable quantities.
Quality assurance is highly regarded by the industry as invaluable in the reproducibility of raw materials. GWB adheres to stringent guidelines for the production of its raw materials so that exacting specifications are achieved. A Certificate of Analysis coherently and succinctly identifies the product, its purity, lot size and contamination content. Calibration to International Standards (World Health Organization, WHO) are performed to ensure consistency in units with established criteria. Storage conditions are given to ensure the product remains intact after receipt by our customers.
Feasibility projects are welcome at GWB to assist the end user in development of new products to meet their market research recommendations. GWB employs scientists in all areas of immunology as well as the physical science disciplines. This blending of scientific knowledge makes it possible to provide our costumers with real tie results without substantial front money. GWB welcomes the opportunity to provide technical assistance so that fruitful and rewarding cooperation may lead to marketable products.
Service plays a major role in our commitment to provide the total partnership required by the medical device industry. This includes on-time delivery, package integrity, proper shipping conditions as well as complete tracking control. GWB places total customer satisfaction as the ultimate goal on its business pursuits. Golden West Biologicals' FDA Blood Establishment Registration number is 2029037. Golden West Biologicals' state of California FDA Device Manufacturing License number is 47709 and 45092.
